510(k) Report

Devices descending from K871465

13 later devices reach Thermometer Sheaths through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983406Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral…Banta Healthcare Group, Ltd.199812—
+2K183431Medline Digital Rectal Thermometer SheathMedline Industries, Inc.20191—
+2K112289Disposable Thermometer Covers and SheathsKang ZE Industrial Co. Limited20111—
+2K083419Actherm Digital Clinical Thermometer Probe Covers, Model (S) MEDACCU1010, MEDACCU1010-1…Actherm, Inc.20090—
+2K063418Acon Digital Thermometer Probe CoversACON Laboratories, Inc.20071—
+2K061007Good Medy, Disposable Thermometer SheathsGood Medy Enterprise, Ltd.20065—
+2K011929Handpiece Sheath-Model #A910Aaron Medical, Inc.20010—
+2K994211Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285Dentsply Intl.20000—
+3K211931Medline Digital Thermometer Non-Lubricated Probe SheathMedline Industries, Inc.20210—
+3K152690Disposable Thermometer Probe SheathsPinghu Sama Medical Packing Co., Ltd.20160—
+3K102508YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02Yu Long Sheng Technology Co., Ltd.20112—
+4K202009Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009…Shenzhen Juzhong Technology Co., Ltd.20210—
+4K180714Probe Covers for ThermometersK-Jump Health Co., Ltd.20180—